AB0899 A 24-month Prospective Psoriatic Arthritis Observational Study of Persistence of Treatment (PRO-SPIRIT) - Interim Analysis of Baseline Characteristics
Authors: J. Morel, L. Dagna, B. Joven-Ibáñez, T. Holzkaemper, C. El Baou, L. Unger, A. Semeraro, N. Gullick, T. Treuer
Journal: Annals of the Rheumatic Diseases (2022)

Background Ixekizumab (ixe), a highly selective interleukin (IL)-17A monoclonal antibody, has been approved for treatment of psoriatic arthritis (PsA). However, there is limited real-world evidence (RWE) available for ixe. PRO-SPIRIT is the first large-sample prospective observational study to provide RWE for ixe in patients (pts) with PsA. Objectives PRO-SPIRIT’s primary objective is to describe treatment persistence at 24 months (M) among pts with PsA who initiate or switch to a new biologic Disease Modifying Arthritis Rheumatic Drugs (bDMARDs) or targeted synthetic (tsDMARDs), including ixe. This abstract describes the interim baseline (BL) characteristics. Methods PRO-SPIRIT is a prospective observational study, conducted in FR, ES, IT, DE, UK, and CA, enrolling adults with PsA (≥6M) to be initiated or switched to a new b/tsDMARD, locally approved for PsA. Treatment groups include ixe, secukinumab, IL-12/IL-23 inhibitors (i) (ustekinumab) or IL-23i (guselkumab), tumour necrosis factor (TNFi) (adalimumab, etanercept, infliximab or biosimilar), Janus kinase (JAKi) (tofacitinib or upadacitinib). Pt demographic, disease activity and therapy characteristics are collected at BL; clinical and patient-reported outcomes measures are collected at BL and at a routine post-BL visit. BL descriptive statistics are reported. Results From December 2019 until this interim data cut (June 2021), a total of 477 pts (305 female; mean age 52) were enrolled. Mean age ranged from 48 (IL-12/23i and IL-23i) to 55 (JAKi), with a majority of female pts in each group (Table 1). Pts in the IL-12/23i and IL-23i and TNFi groups showed the shortest time since PsA diagnosis (5.2±4.5; 6.5±7.9), while pts in the JAKi group showed the longest time (10.6±9.4). The lowest proportion of pts with a prior b/tsDMARDs use was observed in the TNFi group (31%), the highest in the IL-12/23i and IL-23i group (71%). Pts in the ixe and IL-12/23i and IL-23i groups were more likely to be on monotherapy. Tender Joint Count (9.1-11.3) and Swollen Joint Count (3.3-5.8) were comparable across groups, with the highest values in the ixe and JAKi groups, respectively. Pt proportion with enthesitis and dactylitis was higher in the ixe, secukinumab and JAKi groups. Percentage of Body Surface Area affected by psoriasis was higher in the ixe, secukinumab and IL-12/23i and IL-23i groups. Pt proportion with nail psoriasis was higher in the ixe and secukinumab groups. Physician’s Global Assessment Visual Analog Scale (VAS), Patient’s Global Assessment VAS and Patient’s Assessment of Joint Pain VAS reflected a high burden of illness. Table 1. Baseline characteristics bDMARDs tsDMARDs Ixekizumab Secukinumab IL-12/23 and IL-23 inhibitors TNF inhibitors JAK Inhibitors N=137 N=46 N=24 N=211 N=40 Age 52.8±12.2 52.8±13.1 47.6±13.4 50.3±11.7 55.3±9.9 Female, n (%) 86 (62.8) 31 (67.4) 16 (66.7) 135 (64.0) 25 (62.5) Years since diagnosis 8.4±7.5 7.6±8.0 5.2±4.5 6.5±7.9 10.6±9.4 Prior b/tsDMARD, n (%) 87 (63.5) 27 (58.7) 17 (70.8) 66 (31.3) 26 (65.0) Concomitant csDMARD, n (%) 47 (34.3) 19 (41.3) 5 (20.8) 108 (51.2) 19 (47.5) Tender Joint Count 11.3±10.2 9.1±10.8 9.1±9.3 10.9±10.6 11.1±8.8 Swollen Joint Count 5.7±6.6 3.3±3.8 3.4±6.4 4.8±5.6 5.8±6.6 Body Surface Area % affected by psoriasis 6.1±10.5 7.6±14.2 7.0±9.7 4.6±11.0 2.2±3.1 Presence of enthesitis, n (%) 58 (42.3) 16 (34.8) 4 (16.7) 67 (31.8) 16 (40.0) Presence of dactylitis, n (%) 33 (24.1) 10 (21.7) 3 (12.5) 26 (12.3) 10 (25.0) Presence of nail psoriasis, n (%) 57 (41.6) 20 (43.5) 7 (29.2) 71 (33.6) 11 (27.5) Physician’s Global assessment VAS 62.6±18.1 59.5±20.5 55.7±24.6 61.7±18.0 63.0±20.5 Patient’s Global Assessment VAS 60.5±20.4 56.8±25.1 56.2±25.7 57.5±22.9 55.4±22.5 Patient’s Assessment of Joint Pain VAS 62.7±21.3 58.4±27.1 55.7±28.3 59.4±22.9 57.5±24.0 Mean±SD, unless otherwise stated Conclusion The reported BL characteristics offer preliminary information about which pts initiate or switch to a b/tsDMARD in a real life-setting. Future disclosures (at 12 and 24M) will provide RWE regarding persistence, effectiveness, and health care resource use of available treatments for PsA, which will help pts and physicians to make better informed treatment decisions. Disclosure of Interests Jacques Morel Speakers bureau: Abbvie, Amgen, Biogen, Biogen, Bristol Myer Squib, Fresenius, Galapagos, Eli Lilly and Company, Médac, Novartis, Sandoz, Sanofi, Consultant of: Abbvie, Galapagos, Eli Lilly and Company, Médac, Novartis, Glaxo Smith Kline, Grant/research support from: Bristol Myer Squib, Biogen, Eli Lilly and Company, Novartis, Pfizer, Lorenzo Dagna Speakers bureau: Abbvie, Amgen, BMS, Eli Lilly and Company, Galapagos, GSK, Pfizer, Sobi, Consultant of: Abbvie, Amgen, Astra Zeneca, Biogen, BMS, Celltrion, Eli Lilly and Company, Galapagos, GSK, Janssen, Kiniksa, Pfizer, Roche, Sobi, Sanofi, Beatriz Joven-Ibáñez Speakers bureau: Eli Lilly and Company, Grant/research support from: (institutional grant) Eli Lilly and Company, Thorsten Holzkaemper Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Celine El Baou Consultant of: Eli Lilly and Company, Leonore Unger Speakers bureau: Eli Lilly and Company, Angelo Semeraro: None declared, Nicola Gullick Speakers bureau: AbbVie, Celgene, Janssen, Eli Lilly and Company, Novartis, UCB, Consultant of: AbbVie, Janssen, Eli Lilly and Company, Novartis, UCB, Grant/research support from: (institutional grants) Eli Lilly and Company, AbbVie, Astra Zeneca, Izana, Novartis, Tamas Treuer Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company